MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FABIUS TIRO; ANESTHESIA UNITS

Model Number	8606000
Medical Device Problem Codes	Degraded (1153); Failure to Deliver (2338); No Pressure (2994)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
It was reported that the unit had a ventilator failure at the start of the case, the unit was rebooted and staff was able to finish the case.No patient injury resulting from the event.
Additional Manufacturer Narrative
The device was subject to an on-site evaluation by an engineer of the local dräger s&s organization where a faulty light barrier cable as part of the motor assembly has been identified as the root cause.The manufacturer investigation was based on the log file.Log file evaluation revealed the supervisor software had detected two consecutive encoder check errors (wrong motor position) during the concerned procedure and forced a shut-down of automatic ventilation which was accompanied by a corresponding alarm.The entries indicate that the ventilator failure was related to an intermittent stalling of the motor.The described malfunction was duplicated during the onsite device inspection as well.After a short period of time auto ventilation was not possible.The motor speed is being monitored continuously; speed fluctuations caused e.G.By issues with the light barrier and resulting intermittent electrical contact interruptions will result in a deviation between measured and expected piston position.To prevent from damages the system is designed to shut down automatic ventilation and to alert the user to this condition by means of a corresponding alarm.Manual ventilation and the monitoring functions remain available to the full extent.The faulty light barrier cable was replaced onsite, the workstation passed all consecutive tests and was returned to use.The repair exchange of the motor assembly has fully solved the device problem.Dräger finally concludes that the device behaved as specified upon the malfunction of a single component; no patient consequences have been reported.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
Event or Problem Description
It was reported that the unit had a ventilator failure at the start of the case, the unit was rebooted and staff was able to finish the case.No patient injury resulting from the event.

• Brand Name: FABIUS TIRO
• Common Device Name: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 21729717
• Report Number: 9611500-2025-00162
• Device Sequence Number: 8797756
• Product Code: BSZ
• UDI-Device Identifier: 04048675041474
• UDI-Public: (01)04048675041474(11)210602(93)8606000-91
• Combination Product (Y/N): N
• PMA/510(K) Number: K042419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8606000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/10/2025
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NA.; NA.
• Patient Sex: Unknown